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Amgen : Lumakras Gets Positive CHMP Opinion For Advanced Non-Small Cell Lung Cancer

Amgen (AMGN) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending conditional marketing authorization of Lumakras (sotorasib), known as Lumakras in the U.S., for the treatment of adults with advanced non-small-cell lung cancer or NSCLC with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

The CHMP based its positive opinion on results from the Phase 2 CodeBreaK 100 clinical trial. In the trial, LUMYKRAS demonstrated favorable efficacy and tolerability in these 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy.

LUMYKRAS 960 mg, administered orally once-daily, demonstrated an objective response rate of 37.1%, a median duration of response (DoR) of 11.1 months, disease control rate (DCR) of 80.6% and median overall survival (OS) of 12.5 months.

The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by mid-January 2022.

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